Accomplishments: * Compliance- Maintained compliance with regulatory standards. Ensuring site staff was trained and followed all guidelines set forth by the FDA. * Implementation-Implemented a new tracking system that resulted in improved query resolution. * Documentation-Ensured study sites followed ALCOA to ensure accuracy of through precise documentation. * Patient Safety-Ensured quality control through following ICH/GCP. Senior Regional Site manager Covance September 2015 to June 2017 MONITOR THE CONDUCT OF CLINICAL TRIALS ENSURING PATIENT SAFETY. COMPLETE REDUCED SDV AND REMOTE MONITORING TO ENSURE DATA QUALITY. ENSURE COMPLETE AND THOROUGH TRIAL PRODUCT RECONCILIATION ENSURE THE SITE TRIAL MASTER FILE AND THE ETMF ARE UP TO DATE AT ALL TIMES VERIFY SITES ARE ADHERING TO ICH/GCP. I WAS RESPONSIBLE FOR MONITORING ALL ASPECTS OF CLINICAL TRIALS SUCH AS PRE-STUDY, SITE INITIATION, INTERIM AND CLOSE OUT VISITS. I WAS RESPONSIBLE FOR NAVIGATING CTMS, EDC AND ALL OTHER RELATED CLINICAL TRIAL SYSTEMS. MANAGE INVESTIGATOR SITES TO ENSURE THE QUALITY OF DATA AND TRAIN THE SITES ON THE PROTOCOL, EDC, IP DEPOT SYSTEM AS WELL AS ASSIST SITES WITH BEING AUDIT READY AT ALL TIMES. ACTED AS A LEAD CRA WHILE THE CTL IS OUT ILL OR ON PTO. RESPONSIBLE FOR BEING INDEPENDENT AND MAKING TRAVEL ARRANGEMENTS USING THE ONLINE BOOKING TOOL AND COMPLETING EXPENSES IN A TIMELY MANNER.

Highlights:

• Audit
• Compliance
• Data Quality
• Documentation
• Forth Programing Language
• Good Clinical Practices
• ICH
• Management
• Monitoring
• Protocol